顺氯氨铂冻干粉注射剂CISPLATIN(PLATINOL-AQ 1MG/ML 100ML)

产地国家:美国

处方药:是

所属类别: 1毫克/毫升 100毫升/瓶

包装规格: 1毫克/毫升 100毫升/瓶

计价单位:瓶

生产厂家英文名:CORDEN PHARNA

原产地英文商品名:PLATINOL-AQ 1MG/ML 100MLS/VIAL

原产地英文药品名:cisplatin

中文参考商品译名:PLATINOL-AQ 1毫克/毫升 100毫升/瓶

中文参考药品译名:顺氯氨铂

简介:

部份中文PLATINOL-AQ 处方资料(仅供参考)

【分类】其他抗肿瘤药及辅助治疗药

【别名】氯氨铂;顺铂;顺-双氯双氨络铂,双氯双氨络铂,威力顺铂,顺式铂,氨氯铂,锡铂,顺氯氨铂

【外文名】Cisplatin,Cis-Platium,DDP,PDD,NSC-119875,Randa,Neoplatin,Platinol

【适应症】抗瘤谱较广,临床用于治疗睾丸恶肿肿瘤,对胚胎瘤和精原细胞瘤均有较好效果,与常用药物无交叉耐药。对卵巢癌、乳腺癌和膀胱癌有较好疗效。对头颈部癌、肺癌、食管癌、恶性黑色素瘤、恶性淋巴瘤软组织肉瘤和癌性胸腹水等也有一定疗效。与其他抗癌药联合应用效果更好。

【用量用法】1.一般剂量:每平方米体表面积20~30mg溶于等渗盐水200ml中静滴,连用3~5日(总量150mg),间隔3周再重复,可重复用药3~4疗程。2.高剂量:每平方米体表面积80~120mg,同时进行水化和利尿,每3周用药1次,可重复3~4次。3.胸腹腔注射:每次30~60mg,7~10日1次。

【注意事项】1.消化道反应有食欲减退、恶心、呕吐、腹泻等。一般于注射后1~2小时发生,持续4~6小时或更长,停药2~3日后消失。但也有少数病人可持续1周以上。2.骨髓抑制:主要表现白细胞减少,多发生于剂量超过1日每平方米体积100mg时,血小板减少相对较轻。3.听神经毒性与总剂量有关,表现为耳鸣、耳聋、头昏,严重者可有不可逆的高频听力丧失。4.肾脏毒性表现为血尿及肾功能损害,血清肌酐升高及清除率降低,与所用总量有关,常发生于治疗后7~14日之间。5.尚有人报告少数病人可出现心电图ST-T改变,肝功能损伤等。6.有以下情况时应停用本品:(1)白细胞低于3500/μl;(2)血小板低于7.5万/μl;(3)持续性恶心呕吐;(4)早期肾脏毒性如尿中白细胞10/高倍视野、红细胞5/高倍视野或管型5/高倍视野以上者;(5)血清肌酐超过1.5mg/日者;(6)既往患过肾肝疾患、肾功能不好及患过中耳炎的病人。7.为了减轻毒性反应,用药期间应多饮水或输液,强迫利尿;药前先给甲氧氯普胺(胃复安)和氯丙嗪等减轻消化道反应;经常检查血、尿、肝、肾功能及听力。8.过敏反应发生快,如有的病人仅在用药几分钟后出现面部水肿、哮鸣、心动过速和低血压。9.本品具有诱变性、致畸性和可能的致癌性。

【规格】注射用顺铂:每支10mg、20mg。

英文版说明书:

Platinol-AQ (Cisplatin) – Indications and DosageINDICATIONSPLATINOL-AQ (cisplatin injection) is indicated as therapy to be employed as follows:Metastatic Testicular TumorsIn established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures.Metastatic Ovarian TumorsIn established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of PLATINOL-AQ and cyclophosphamide. PLATINOL-AQ, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received PLATINOL-AQ therapy.Advanced Bladder CancerPLATINOL-AQ is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy.DOSAGE AND ADMINISTRATIONPLATINOL-AQ is administered by slow intravenous infusion. PLATINOL-AQ SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.Note: Needles or intravenous sets containing aluminum parts that may come in contact with PLATINOL-AQ should not be used for preparation or administration. Aluminum reacts with PLATINOL-AQ, causing precipitate formation and a loss of potency.Metastatic Testicular TumorsThe usual PLATINOL-AQ dose for the treatment of testicular cancer in combination with other approved chemotherapeutic agents is 20 mg/m2 IV daily for 5 days per cycle.Metastatic Ovarian TumorsThe usual PLATINOL-AQ dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75 to 100 mg/m2 IV per cycle once every four weeks (DAY 1).The dose of cyclophosphamide when used in combination with PLATINOL-AQ is 600 mg/m2 IV once every 4 weeks (DAY 1).For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert.In combination therapy, PLATINOL-AQ and cyclophosphamide are administered sequentially.As a single agent, PLATINOL-AQ should be administered at a dose of 100 mg/m2 IV per cycle once every four weeks.Advanced Bladder CancerPLATINOL-AQ should be administered as a single agent at a dose of 50 to 70 mg/m2 IV per cycle once every 3 to 4 weeks depending on the extent of prior exposure to radiation therapy and/or prior chemotherapy. For heavily pretreated patients an initial dose of 50 mg/m2 per cycle repeated every 4 weeks is recommended.All PatientsPretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a PLATINOL-AQ dose is recommended. The drug is then diluted in 2 liters of 5% Dextrose in 1/2 or 1/3 normal saline containing 37.5 g of mannitol, and infused over a 6- to 8-hour period. If diluted solution is not to be used within 6 hours, protect solution from light. Do not dilute PLATINOL-AQ in just 5% Dextrose Injection. Adequate hydration and urinary output must be maintained during the following 24 hours.A repeat course of PLATINOL-AQ should not be given until the serum creatinine is below 1.5 mg/100 mL, and/or the BUN is below 25 mg/100 mL. A repeat course should not be given until circulating blood elements are at an acceptable level (platelets ≥100,000/mm3, WBC ≥4000/mm3). Subsequent doses of PLATINOL-AQ should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.PREPARATION OF INTRAVENOUS SOLUTIONSPreparation PrecautionsCaution should be exercised in handling the aqueous solution. Procedures for proper handling and disposal of anticancer drugs should be utilized. Several guidelines on this subject have been published.1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and IV sets containing PLATINOL-AQ.Skin reactions associated with accidental exposure to cisplatin may occur. The use of gloves is recommended. If PLATINOL-AQ contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water. More information is available in the references listed below.Instructions for PreparationThe aqueous solution should be used intravenously only and should be administered by IV infusion over a 6- to 8-hour period (see DOSAGE AND ADMINISTRATION).Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.NOTE TO PHARMACIST: Exercise caution to prevent inadvertent PLATINOL-AQ overdosage. Please call prescriber if dose is greater than 100 mg/m2 per cycle. Aluminum and flip-off seal of vial have been imprinted with the following statement:CALL DR. IF DOSE>100 MG/M 2 /CYCLE.STABILITYPLATINOL-AQ is a sterile, multidose vial without preservatives.Store at 15° C to 25° C. Do not refrigerate. Protect unopened container from light.The cisplatin remaining in the amber vial following initial entry is stable for 28 days protected from light or for 7 days under fluorescent room light.HOW SUPPLIEDPLATINOL®-AQ (cisplatin injection)NDC 61126-004-01—Each multidose vial contains 50 mg of cisplatinNDC 61126-004-02—Each multidose vial contains 100 mg of cisplatin

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